Senior Labeling Hub Manager
Core
Develop and execute labeling strategies and project plans for generic and branded pharmaceutical products across the European Economic Area, ensuring compliance with regional regulations and supporting end-to-end artwork implementation.
Role type
Senior Labeling Hub Manager (Regulatory & Project Management)
Builds
Regulatory-compliant labeling dossiers, artwork implementations, and regional labeling strategies for Pan European markets.
Domain
Healthcare / Pharmaceuticals / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory affairs expertise, project management, team leadership, cross-functional collaboration, strategic guidance, compliance management, document control, change control management, stakeholder communication, audit participation
Preferred skills
Experience with electronic submission systems (e.g., Lorenz), experience with change control systems (e.g., TrackWise), knowledge of document management systems, experience in global environments
Technologies
Lorenz, TrackWise
Responsibilities
Lead cross-functional teams in global labeling projects; manage and develop regional labeling team members; provide strategic regulatory guidance for new and approved dossiers; review and assess Core Data Sheets (CCDS) for labeling updates; liaise with legal and quality teams; ensure timely implementation of new regional laws and regulations; participate in internal and external audits.
Seniority
Senior, hands-on IC with leadership responsibilities
